In this course, participants will learn the process for developing an effective Corrective and Preventive Action Plan (CAPA). It will cover when and why CAPAs are needed, ways to identify a root cause, and tools to facilitate the process.
This training provides an introduction to secondary research, including how to prepare documents for COMIRB review. Time will be reserved to discuss your secondary research projects.
This course will discuss the PI's additional responsibilities when COMIRB is serving as sIRB, explain the process and procedures for COMIRB, the PI, and the relying sites, and explain when and how the Smart IRB network is used for this purpose.
